Vacuum assisted biopsy needle set

ABSTRACT

A needle set for a biopsy device is disclosed. The needle set includes an outer member, a cylinder lumen within said outer member, an inner member having a cannula and an inner lumen. The inner member is slidably disposed within the cylinder lumen. The biopsy device also includes a cylinder seal member that is disposed within the cylinder lumen and a cannula seal member attached to the outer surface of the cannula. The cylinder seal member and the cannula seal member define a vacuum chamber therebetween.

CROSS REFERENCE TO RELATED APPLICATION

This application claims priority based upon U.S. provisional patentapplication Ser. No. 60/510,866 filed on Oct. 14, 2003, which isincorporated herein by reference in its entirety.

FIELD OF THE INVENTION

The present invention generally relates to the field of tissue samplingand harvesting. More specifically, the invention relates to biopsyneedle sets.

BACKGROUND OF THE INVENTION

In the practice of diagnostic medicine, it is often necessary ordesirable to perform a biopsy, or to sample selected tissue from aliving patient for medical evaluation. Cytological and histologicalstudies of the biopsy sample can then be performed as an aid to thediagnosis and treatment of disease. Biopsies can be useful in diagnosingand treating various forms of cancer, as well as other diseases in whicha localized area of affected tissue can be identified.

Biopsies are routinely performed on tissue using a needle set, whichtypically includes a stylet with a pointed tip and a notch defined nearits distal end. The stylet is slidably disposed within a cannula so thatthe notch can be alternately exposed or covered. Typically, a hub isconnected to the proximal end of each needle. Such needle sets are usedwith or incorporated in various forms of biopsy devices, such as thesingle action and double action biopsy devices that are available fromPromex/US Biopsy, LLC, 3049 Hudson Street, Franklin, Ind. 46131, (317)736-0128. For example, such a needle set is incorporated into the singleaction biopsy device shown in FIGS. 1-4.

Referring to FIGS. 1-4, single action biopsy device 20 includes an outerhollow needle 22 defining a lumen 24 therethrough. A stylet 26 isslidingly disposed within lumen 24 and is moveable relative to outerneedle 22. A first or distal end 28 of stylet 26 is provided with atissue cutting-point 30 and a cavity 32 adjacent to first end 28 forreceiving tissue samples. Stylet 26 is slidable relative to outer needle22 between a first or retracted position (FIG. 3) and a second orextended position (FIG. 2).

In the first position, stylet 26 is retracted within lumen 24 so thatouter needle 22 covers cavity 32. In the second position, the first end28 of stylet 26 is extended away from outer needle 22 to expose cavity32 to tissues at the biopsy site.

During a biopsy procedure, device 20 will be positioned with the cavity32 at the targeted site for the biopsy. Stylet 26 is momentarily driveninto the tissue far enough to expose cavity 32. Tissue then prolapsesinto cavity 32. The device is then fired to advance outer needle 22along stylet 26 to cover cavity 32. This forward movement of outerneedle 22 severs the prolapsed tissue to obtain a tissue sample, whichbecomes trapped in cavity 32 of stylet 26. With outer needle 22 blockingthe opening of cavity 32, biopsy device 20 is then withdrawn from thetarget site, carrying the sample within cavity 32. To collect the biopsysample, outer needle 22 is once again retracted to expose cavity 32 ofstylet 26. The procedure may be repeated several times untilsatisfactory samples have been obtained.

The firing mechanism for such single action biopsy devices is shown inFIG. 4. Biopsy device 20 is provided with a firing mechanism 40, whichincludes a housing 27 having finger grips 41 and 42. An actuator 43 isoperatively engaged with both the stylet 26 and outer needle 22.Actuator 43 includes a gripping portion 44 and a drive mechanism 45.Drive mechanism 45 operates to depress a drive carriage 46 against theaction of a spring 35. Housing 27 includes a resilient latch 36 thatengages an underside 47 of the carriage 46 in the retracted position.Latch 36 is released by forward movement of the drive mechanism 45 sothat the spring 35 urges carriage 46 outwardly, which in turn thrustsouter needle 22 over the sampling cavity 32 of the stylet 26. Cover 49snap-fits over housing 27 to protect spring 35 and the slidingengagement between carriage 46 and housing 27 from debris andinterference.

Double action biopsy devices also employ similar needle sets. In adouble action biopsy device, movement of inner and outer needles 26, 22to capture a sample occurs almost instantaneously by means of a firingmechanism engaged with proximal ends 29 of needles 26, 22. A doubleaction biopsy device is disclosed in U.S. Pat. No. 5,538,010 to Darr andIreland.

While these single and double action biopsy devices are widely used, abasic problem remains in the field of biopsy, which is the need toobtain a sufficient amount of sample tissue. One potential cause of theproblem is that as the outer needle passes over the tissue cavity, theouter needle has a tendency to push the tissue away from the cavity.This results in samples that are inferior in quality or too small, whichprecludes the pathologist from conclusively determining whether diseaseis present, and if so, to what extent it has progressed. The pathologistmust then issue an inconclusive diagnostic report. This causes thephysician to recall the patient and attempt another needle biopsy, or insome situations, the patient is scheduled for a more invasive, traumaticand expensive procedure such as an open surgical biopsy.

The challenge has been to consistently obtain sufficient tissue volumeand quality tissue cores, regardless of tissue type, to meet the needsof the pathologist so that a conclusive diagnosis can be achieved.Therefore, a need remains for advice that can consistently achieve thisresult.

SUMMARY

The present invention provides a needle set for a biopsy device havingan inner member and an outer member, in which the outer member includesa cylinder lumen with a cylinder seal member disposed therein. The innermember includes a cannula, an inner lumen, and a sampling portion. Theinner member is slideably disposed within the cylinder lumen through thecylinder seal member. A cannula seal member is engaged with an outersurface of the cannula. The cylinder seal member and cannula cooperateto define a vacuum chamber. The movement of the outer cannula to adistal position generates vacuum which is delivered to the inner cannulalumen, thereby creating vacuum in the sampling portion of the innermember. The vacuum created in the sampling portion securely retainstissue samples, resulting in more reliable sampling and larger samplevolumes.

BRIEF DESCRIPTION OF DRAWINGS

FIG. 1 is a side elevational view of a prior art biopsy device;

FIG. 2 is an enlarged fragmentary view of the device of FIG. 1, showingdetails of the tip of the device when in an extended position;

FIG. 3 is an enlarged fragmentary view of the device of FIG. 1 showingdetails of the tip when in a retracted position;

FIG. 4 is an exploded view of the device of FIGS. 1-3.

FIG. 5 is a partial sectional view showing a needle set having an outermember and an inner member according to an embodiment of the presentinvention;

FIG. 6 is a side elevational view of an outer member of the needle setof FIG. 5;

FIG. 7 is a side elevational view of an inner member of the needle setof FIG. 5;

FIG. 8 is a partial side sectional view of the needle set in a first orretracted position;

FIGS. 9A and 9B are partial side sectional views of the needle set ofFIG. 5 in the second or extended position;

FIG. 10 is an enlarged side elevational view of the distal end of theneedle set of FIG. 5;

FIG. 11 is a side sectional view of the distal end of another embodimentof a needle set according to an embodiment of the present invention;

FIG. 12 is a cross sectional view of the needle set of FIG. 11 takenalong line 12-12 of FIG. 11.

FIG. 13 is a cross sectional view of the needle set of FIG. 11 takenalong line 13-13.

FIG. 14 is a perspective view of the needle set of FIG. 5 having afiring mechanism;

FIGS. 15-17 show the construction of the inner member of FIG. 7; and

FIG. 18 is a sectional view of a portion of the inner member of FIG. 7.

Although the drawings represent embodiments of the present. invention,the drawings are not necessarily to scale and certain features may beexaggerated in order to better illustrate and explain the presentinvention. The exemplification set out herein illustrates certainembodiments of the invention, in one, or more forms, and suchexemplifications are not to be construed as limiting the scope of theinvention in any manner.

DETAILED DESCRIPTION

For the purposes of promoting an understanding of the principles of theinvention, reference will now be made to the embodiments illustrated inthe drawings and specific language will be used to describe the same. Itwill nevertheless be understood that no limitation of the scope of theinvention is thereby intended. The invention includes any alterationsand further modifications in the illustrated devices and describedmethods and further applications of the principles of the invention thatwould normally occur to one skilled in the art to which the inventionrelates.

The terms proximal and distal as used herein will be understood todescribe opposite ends of a device or element, and generally will beemployed so that proximal is understood as “toward the heart” and distalis understood to mean “away from the heart” or “away from thepractitioner” and “toward the practitioner,” respectively.

FIGS. 5-10 depict a needle set 50 for a biopsy device made in accordancewith the present invention. Needle set 50 includes an inner member 100slidably disposed within a lumen of an outer member 60. Outer member 60has a tip member 61 attached to a cylinder portion 70 of outer member 60and a hub member 80 positioned on the proximal end of outer member 60.Tip member 61 has a working end 63 with an opening 63(a), an oppositeend 64 and a tip lumen 65 defined therebetween. As seen most clearly inFIG. 6, cylinder portion 70 has a first end 71 hermetically connected tothe opposite end 64 of the tip member 61 and a second end 73. A cylinderlumen 75 is defined between first and second end 71 and 73. The cylinderlumen 75 is in fluid communication with the tip lumen 65. Hub member 80is positioned on the second end 73 of the cylinder. Hub member 80defines a hub lumen 85 in fluid communication with the cylinder lumen75. The hub lumen 85 is also in fluid communication with a pair ofopenings 86 a, 87 a defined in opposite sides 86, 87 of the hub member80. A vent seal 88 is disposed within the hub member 80. The second end73 of the cylinder portion 70 is attached to hub member 80 at one of theopposite sides 86 and positioned so that the cylinder lumen 75 isaligned with the hub lumen 85.

A cylinder seal member 90 is positioned within the cylinder lumen 75 andfixed to the interior surface of the cylinder 70. The cylinder sealmember 90 is any suitable seal member, such as for example, an O-ring.Cylinder seal member 90 defines an opening 91, which is in communicationwith the cylinder lumen 75.

Referring now to FIG. 7, inner member 100 includes a cannula 110 and asampling portion 150. Cannula 110 may be slidably disposed within thecylinder lumen 75 and through the opening 91 of the cylinder seal member90 as shown in FIG. 5. An inner lumen 115 is defined between the distaland proximal ends 101, 102. Cannula 110 defines an opening 120 and avent aperture 156 adjacent the proximal end 102. Both the opening 120and vent aperture 156 are defined through the wall of the cannula 110and are in fluid communication with the inner lumen 115. While opening120 is shown as a notch, it is understood that opening 120 may take theform of other configurations without departing from the invention.

Sampling portion 150 is attached to the distal end 101 of cannula 110.Sampling portion 150 defines a sampling cavity 155. Sampling portion 150may also be provided with a tissue piercing tip 153. A cannula sealmember 160 is fixed to the outer surface of the cannula 110 proximal tothe opening 120. Cannula seal member 160 is configured to movably sealwithin the cylinder lumen 75 of FIG. 6.

As shown in FIG. 8, the cannula seal member 160 and the cylinder sealmember 90 cooperate to define a vacuum chamber VC. The opening 120 maybe disposed within the vacuum chamber VC. The inner and outer members60, 100 are movable relative to one another between a retracted positionin which the tip member 61 covers the sampling cavity 155 and the vacuumchamber VC is expanded, and an extended position. The needle set may beplaced in a cocked position as shown in FIG. 8 with the vent aperture156 exposed to vent air from the inner lumen 115 as the needle set ismoved to the extended position (as shown in FIG. 9A) such that movementof the outer member 60 to the distal position generates vacuum which isdelivered to the inner lumen 115. In the extended position the samplingportion 150 is extended away from the tip member 61 to expose thesampling cavity 155 and the vacuum chamber VC is contracted. The ventaperture 156 is sealed by the vent seal 88 when the needle set iscompletely in the extended position.

As the device is cocked, the inner member 100 is pulled towards theoperator, which exposes the vent aperture 156 beyond the proximal end 87of the hub 80 of the outer cannula 60, as shown in FIG. 8. Referring toFIG. 9B, the inner needle 100 is pushed forward to expose the cavity 155to tissue, the vacuum chamber VC is collapsed, as indicated by thecloser proximity between the cannula seal member 160 and the cylinderseal member 90. Accordingly, air is vented out through the vent aperture156 along the direction of arrow A. The vent aperture 156 is designed toprevent pushing air out though the cavity 155. Firing the device causesthe outer member 60 to move distally, which expands the vacuum chamberVC. Expanding the vacuum chamber VC creates a vacuum in the inner lumen115, which is communicated to the cavity 155 as the vent aperture 156 issealed within vent sleeve 88 disposed within the hub lumen 85. Thevacuum generated in the extended position serves to bias the tissuetoward the sampling cavity 155 and hold the tissue in place while thesuspect tissue is severed. Therefore, vacuum is applied to the tissue incavity 155 as the tip member 61 of the outer member 60 moves over thesampling portion 150 of the inner member 100. In contrast, when priorart devices are used, the outer member will push tissue away from thecavity, reducing the size of the sample or requiring multiple attemptsto capture the sample. In the embodiments of the present invention, thevacuum created by the enlargement of the vacuum chamber holds the tissuein place within the cavity 155 resulting in more reliable sampling andlarger sample volumes.

The needle set may also include a metering mechanism for selectivelyallowing the exchange of air but not tissue between the cavity 155 andthe inner lumen 115. As shown more clearly in FIG. 10, in one particularembodiment, the metering mechanism includes a filter member 180 fittedwithin the inner lumen 115 or disposed between the inner lumen 115 andthe sampling portion 150. Materials suitable for the filter member arecommercially available. The selected material should, but notnecessarily, have a pore size that allows the exchange of air but is toosmall for body tissue.

An alternative embodiment of the metering mechanism includes the innermember 110′ shown in FIGS. 11-18. The distal tip member 151′ of samplingportion 150′ includes tissue piercing tip 153′ and a solid insert 158.As illustrated by FIGS. 12-13, solid insert 158 has an outer diameter ODless than the inner diameter ID of the inner lumen 115′ so that air maypass around the insert 158 when the insert is disposed within the innerlumen 115′. As shown, the insert 158 is substantially centered withinthe inner lumen 115′. In alternate embodiments, based on designrequirements, the insert 158 may be shifted to a particular side orportion of the inner lumen 115′ thereby modifying the air flow withinthe inner lumen 115′. The insert 158 and the inner lumen 115′ should be,but not necessarily, dimensioned so that the space between them allowsair to pass but not tissue.

The needle set embodiments herein may be operated via a biopsy device.For example, the needle set can be loaded into a double action biopsydevice or incorporated into a single action biopsy device. FIG. 14illustrates a needle set including an advancing mechanism 159,operatively engaged to the second end 73 of the cylinder 70 and theproximal end 102 of the inner member 100. The advancing mechanism 159 isoperable to move the outer member 60 relative to the inner member 100from the second position to the first position to trap tissue from thebiopsy site in the sampling cavity 155.

The embodiments of the inner member 100 described herein may beconstructed according to the steps depicted in FIGS. 15-18. As shown inFIG. 15, insert 158 may be attached to a connecting element 158 a and ablank 151″. As shown in FIG. 16, insert 158 is positioned within thelumen 115′ of the cannula 110′, with the cannula 110′ friction fitted tothe connecting element 158 a. The connecting element 158 a could be aring or a pair of projections, for example. The sampling cavity 155′ isthen machined through a distal portion 101′ of the cannula 110′ and intothe solid insert 158 to achieve the configuration shown in FIGS. 17-18.The inner member 100 may be inserted into the cylinder lumen 75 of theouter member 60 (as shown in FIG. 8). A tissue piercing tip can beformed at any point in the process, using any suitable methods, such asby machining the blank 151″.

The assemblies of this invention can be provided in any suitable shapeand size and can be manufactured using any suitable materials. In oneparticular embodiment, the needle set is composed of surgical gradestainless steel.

Other embodiments of the invention will be apparent to those skilled inthe art from consideration of the specification and practice of theinvention disclosed herein. It is intended that the specification,drawings and examples be considered as exemplary only, with the truescope and spirit of the invention being indicated by the followingclaims. It should be understood that the embodiments shown and describedand all changes and modifications that come within the spirit of theinvention are desired to be protected.

1-33. (canceled)
 34. A needle set for a biopsy device, comprising: anouter member; a cylinder lumen within the outer member; a cylinder sealmember disposed within the cylinder lumen; an inner member having acannula and an inner lumen, wherein the inner member is slideablydisposed within the cylinder lumen through the cylinder seal member; anda cannula seal member attached to an outer surface of the cannula,wherein the biopsy device will selectively sever tissue as a vacuum isapplied to the tissue.
 35. A needle set according to claim 34, whereinat least the cylinder seal member and the cannula seal member cooperateto define a vacuum chamber therebetween.
 36. A needle set according toclaim 34, wherein the outer member and the inner member are moveablerelative to each other.
 37. A needle set according to claim 34, whereinthe inner member includes a sampling cavity having an opening that is incommunication with the cylinder lumen.
 38. A needle set according toclaim 37, wherein the inner member further includes a piercing tip. 39.A needle set according to claim 34, wherein the outer member furthercomprises: a tip member having a working end, an opposite end and a tiplumen defined therebetween.
 40. A needle set according to claim 34,wherein the inner member includes an opening through the inner memberthat forms a channel between the inner lumen and the cylinder lumen. 41.A needle set according to claim 40, wherein the opening is disposedbetween the cylinder seal member and the cannula seal member.
 42. Aneedle set according to claim 34, wherein a hub member is positioned onan end of the outer member, wherein the hub member includes a lumentherethrough, the lumen being in fluid communication with the innerlumen.
 43. A needle set according to claim 42 further including a ventseal member positioned within the lumen of the hub member, the vent sealmember serving to seal the vent aperture formed in the inner member,when the needle set is in an extended position.
 44. A needle setaccording to claim 34, wherein the inner lumen of the inner memberincludes a porous filter member disposed therein.
 45. A needle setaccording to claim 44, wherein the filter member has a pore size thatprohibits the passage of body tissue.
 46. A needle set according toclaim 34, wherein the inner lumen has a first inner diameter andincludes a distal tip member with a sampling portion; the inner memberfurther including a solid insert having an outer diameter that is lessthan the inner diameter of the inner lumen to create a clearance path sothat air and fluid may pass around the insert when the insert isdisposed within the inner lumen.
 47. A needle set according to claim 46,wherein the solid insert is centered within the inner lumen.
 48. Aneedle set according to claim 34, wherein the cylinder seal member is anO-ring.
 49. A needle set according to claim 34 further comprising anadvancing mechanism engaged to the inner member; the advancing mechanismbeing operable to move the outer member relative to the inner member.50. A needle set according to claim 34, wherein the cylinder seal memberis moved away from the cannula seal member to generate a vacuum to biastissue toward the sampling cavity.
 51. A needle set according to claim34, wherein the vacuum selectively increases generally proportionally tothe distance that the seal member is moved away from the cylinder sealmember.
 52. A needle set for a biopsy device, comprising: an outermember having a tip member and a cylinder lumen; a cylinder seal memberdisposed within the cylinder lumen; a cannula seal member; an innermember having a cannula with the cannula seal member being attached toan outer surface of the cannula, a sampling portion that defines asampling cavity, and an inner lumen, wherein the inner member isslideably disposed within the cylinder lumen through the cylinder sealmember; the cylinder seal member and the cannula seal member defining avacuum chamber; and the inner member and the outer member movablerelative to one another between a retracted position in which the tipmember covers the sampling cavity and the vacuum chamber is expanded andan extended position wherein the sampling portion is extended away fromthe tip member to expose the sampling cavity and the vacuum chamber iscontracted.
 53. A needle set according to claim 52, wherein the innermember further includes a piercing tip.
 54. A needle set according toclaim 52, wherein the inner member includes an opening in fluidcommunication with the inner lumen, the opening being disposed withinthe vacuum chamber.
 55. A needle set according to claim 52, wherein theinner member includes a vent aperture in fluid communication with theinner lumen.
 56. A needle set according to claim 52, wherein the innerlumen of the inner member includes a porous filter member disposedtherein.
 57. A needle set according to claim 56, wherein the filtermember has a pore size that prohibits the passage of body tissue.
 58. Aneedle set according to claim 52, wherein the inner lumen has a firstinner diameter and wherein the inner member further includes a solidinsert having an outer diameter that is less than the inner diameter ofthe inner lumen to create a clearance path so that air and fluid maypass around the insert when the insert is disposed within the innerlumen.
 59. A needle set according to claim 52, wherein the cylinder sealmember is moved away from the cannula seal member to generate a vacuumto bias tissue toward the sampling cavity.
 60. A needle set according toclaim 59, wherein the vacuum selectively increases generallyproportionally to the distance that the seal member is moved away fromthe cylinder seal member.